FDA 510(k)

STELLA BIO

Número K: K210002 · 2021-10-01

Data da decisão2021-10-01

Código do produtoIPF

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

STELLA BIO is the device name listed in this FDA 510(k) record. The listed applicant is Egzotech Sp. Z O. O.. It received FDA 510(k) clearance on 2021-10-01 under 510(k) number K210002. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STELLA BIO?

STELLA BIO is a medical device that received FDA 510(k) clearance on 2021-10-01. The listed applicant is Egzotech Sp. Z O. O.. The 510(k) number is K210002.

When did STELLA BIO receive FDA 510(k) clearance?

STELLA BIO received FDA 510(k) clearance on 2021-10-01, under 510(k) number K210002.

Who is the listed applicant for STELLA BIO?

The FDA 510(k) record lists Egzotech Sp. Z O. O. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STELLA BIO?

The FDA product code for STELLA BIO is IPF.

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